D-0079-2019 Class II Terminated
FDA drug recall D-0079-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions that could impact its product quality. The recall status is terminated (terminated Mar 30, 2021).
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
Reason for Recall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Distribution Pattern
Nationwide in the USA
Code Information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0079-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026